Obesity
Conditions
Keywords
Physical Activity, Workouts, Adipocytokines
Brief summary
The phenomenon of physical activity (PA) avoidance in obesity has been detailed in the literature, but there is a lack of programs designed to address the root causes. In addition to common PA barriers such as lack of time, individuals with obesity face weight-related impediments, including stigma, shame, poor fitness, and low exercise self-efficacy, which reduce their engagement in PA. These impediments have been observed in white and minoritized populations. Numerous studies have suggested that individuals with obesity prefer activities that are enjoyable, less exhausting, and conveniently available in settings where they are not exposed to stigma. The studies also point to a need for programs that focus on the general health benefits of PA rather than weight loss, which although desirable, can be elusive. Unmet weight loss expectations contribute to high dropout rates and non-adherence to the prescribed PA regimen among those with obesity. This is particularly consequential for minoritized populations including African Americans who tend to lose less weight in lifestyle interventions but achieve significant improvements in many cardiometabolic outcomes. In this proposal, investigators present PA as a buffer against the deleterious effects of obesity, agnostic of weight loss status. The Physical Activity for The Heart (PATH) program was intentionally designed to provide vicarious experiences for diverse individuals with obesity, by featuring their peers in body size, fitness level, and age engaging in PA. The impact of the PATH intervention on these biomarkers will provide important insights into the mechanisms via which a combination of popular PA modalities improves cardiometabolic outcomes in the context of obesity.
Detailed description
The proposed research is significant because it will provide key evidence supporting the use of curated, openly sourced content to address PA barriers in obesity. Physical Activity for The Heart (PATH) intervention, which is anchored on the social cognitive theory's (SCT) premise that observing similar (i.e. body type, fitness level, age) others succeed can motivate action and help demonstrate a plan for success. Thus proposal will examine the feasibility of using PATH in a weight-neutral context and the preliminary effects on adipocytokines that influence insulin resistance. If PATH improves PA and adipocytokines, it could provide a highly scalable tool for mitigating the risk of cardiometabolic disease, especially among those looking for weight-agnostic PA programs. The walking, dance, and abdominal core workouts to be examined in this proposal are extremely popular and abundant on YouTube, which makes it easy to access and curate content that can be tailored to individual preferences. The highly scalable PATH program is accessible at any time in any setting and can lessen the impact of unpredictable barriers to PA such as inclement weather or pandemics.
Interventions
BEHAVIORALPATH Intervention
The PATH intervention guides participants in making changes in their lifestyle and PA habits to support gradual improvement of PA. The health coach provides participants with access to the PATH website and instructions on how to use the resources included in PATH. The health coach meets remotely with each participant twice per month to develop a tailored plan geared towards increasing MVPA. After assigning the PATH level, the health coach guides each participant in selecting their weekly PA goal and helps them start slowly with a plan to establish regular exercise frequencies of 3-5 days per week. Participants will use a combination of walking, dance, and abdominal core workouts to add at least 10 minutes of MVPA to their baseline PA every two weeks. The remote coach will encourage each participant to engage in at least 2 days of aerobic training (walking or dance sessions), and one day of abdominal core workouts.
BEHAVIORALControl Group
Study staff will have a Zoom meeting with each control group participant where they will be advised to use the Be Active Your Way handout and to self-monitor PA using ScanWatch. Additionally, the group will be introduced to www.health.com, a jargon-free website that focuses on general health topics (e.g., dry eye) and the latest medical news (e.g., vaccines). Every 2 weeks control participants will meet on Zoom with study staff to review their progress in the study so as to keep the contact between the groups as similar as possible.
Participants will be asked to wear a ScanWatch tracker on their non-dominant hand for the entire duration of the study using a 24-hour wear protocol.
BEHAVIORALDietary education
The research team will examine diet quality and provide all study participants with educational content curated to promote diet quality. To minimize participants' burden, both the intervention and control arms will receive an email with a brief PDF addressing new diet components every 4 weeks
Sponsors
Emory University
Georgia Center for Diabetes Translation Research
American Diabetes Association
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* age ≥18 years, body mass index (BMI) ≥30kg/m2, * regular access to the Internet, * self-monitoring of PA via waist worn Actigraph during run-in (≥4 days with ≥10hrs wear time), * self-reported non-adherence to PA Guidelines \[\<150 min of moderate to vigorous physical activities (MVPA/wk)\].
Exclusion criteria
* pregnancy/intention to become pregnant within 12 weeks, * involvement in litigation related to a health issue, or a condition that requires supervised PA (e.g., stroke). * Individuals with a history of cerebrovascular disease (CVD), type 2 diabetes (T2D), * any affirmative response to any question in the Physical Activity Readiness Questionnaire (PAR-Q) will require primary care physician (PCP) clearance before enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participants Enrolled Within 4 Months of Study Opening | 4 months after screening procedures start | Number of participants enrolled within 4 months after the study opened to enrollment. |
| Number of Participants Retained in Each Group | 12 weeks | Number of participants (Retention rate) retained in each group at 12 weeks after enrollment |
| The System Usability Scale | 12 weeks | The System Usability Scale (SUS) is an industry-standard, 10-item questionnaire used to evaluate the perceived usability of a product, system, or service. It provides a quick, reliable, and quantifiable measure of ease of use and user satisfaction. Users rate their level of agreement or disagreement with 10 statements using a 5-point Likert scale (1 = Strongly Disagree, 5 = Strongly Agree). Responses are converted and summed according to standard SUS scoring and transformed to a total score ranging from 0 to 100. The average score is about 68. A score above 68 is considered above average/good; a score below 68 is below average. Acceptability Ranges: Scores above 70 are typically considered "Acceptable," while scores below 50 usually indicate a system with poorer usability that needs to be redesigned. |
| Participants' Satisfaction of Protocol Procedures (Acceptability) | 12 weeks | Participant satisfaction was assessed using an end-of-study user experience survey. Participants rated navigation ease (extremely easy/very easy) and overall satisfaction with the content and messaging. Navigation ease (extremely/very easy) Cultural appropriateness (very/somewhat appropriate) Workout access (extremely/very easy) Text reminders helpful (extremely/very helpful) |
| Participants' Engagement | 12 weeks | Participants who visited the PATH platform at least twice weekly. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adiponectin and Leptin | Baseline and 12 weeks | Adiponectin is a hormone released by adipose tissue and other body tissues, which assists with insulin sensitivity and reduces inflammation. Normal ranges vary depending on sex and BMI and in general lower levels are associated with health conditions of obesity, Type 2 diabetes, and atherosclerosis. Adiponectin and leptin will be collected via dry blood spot kits. A significant increase in adiponectin and decline in leptin, and T2D risk score will indicate improved adipocytokine and cardiometabolic risk profile and vice versa. |
| Monocyte Chemoattractant Protein-1 (MCP-1) | Baseline and 12 weeks | MCP-1 is one of the key chemokines that regulate the migration and infiltration of monocytes/macrophages. MCP-1 will be collected via dry blood spot kits. A significant decline in MCP-1 will indicate improved adipocytokine and cardiometabolic risk profile and vice versa. |
| Proinflammatory Cytokines | Baseline and 12 weeks | Proinflammatory cytokines: tumor necrosis factor Alpha (TNF-α), Interleukin-1 beta (IL1β), and Interleukin-6 (IL6), and CRP will be collected via dry blood spot kits. A significant decline in TNF-α, IL1β, and IL6 will indicate improved adipocytokine and cardiometabolic risk profile, and vice versa. |
| Insulin Levels | Baseline and 12 weeks | Collected via Dried Blood Spot (DBS) kits |
| Type 2 Diabetes (T2D) Risk Score | Baseline and 12 weeks | The calculation of the American Diabetes Association (ADA) T2D risk score includes covariates such as age, sex, family history of diabetes, history of high blood pressure (BP), body mass index, and PA regimen (total score of 0-11). Scores ≥5 should be formally screened for diabetes per ADA guidelines. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJacob Kariuki, PhD, NP
Emory University
Participant flow
Recruitment details
Participants were recruited from Emory Healthcare System in Atlanta, Georgia, USA. Participant enrollment began April 11, 2024, and all follow-up was completed by May 18, 2025.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 49.5 years STANDARD_DEVIATION 11.7 |
| Blood Pressure (BP) Diastolic BP | 82.2 mmHg STANDARD_DEVIATION 12.1 |
| Blood Pressure (BP) Systolic BP | 133.0 mmHg STANDARD_DEVIATION 18.3 |
| Body Fat Percentage | 44.5 percentage of fat STANDARD_DEVIATION 7.6 |
| Body Mass Index (BMI) | 40.2 Kg/m^2 STANDARD_DEVIATION 8.9 |
| College Educated | 20 Participants |
| Income meets financial needs | 23 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 22 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 14 Participants |
| Region of Enrollment United States | 27 participants |
| Self-reported Moderate-to-Vigorous Physical Activity (MVPA) | 39.4 minutes/week STANDARD_DEVIATION 40.9 |
| Sex: Female, Male Female | 26 Participants |
| Sex: Female, Male Male | 1 Participants |
| Waist Circumference | 47.9 inches STANDARD_DEVIATION 7 |
| Weight | 250.1 lbs STANDARD_DEVIATION 56.4 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 27 | 0 / 27 |
| other Total, other adverse events | 0 / 27 | 0 / 27 |
| serious Total, serious adverse events | 0 / 27 | 0 / 27 |
Outcome results
None listed